Actively Recruiting

Phase 4
Age: 18Years - 80Years
All Genders
Healthy Volunteers
NCT04669717

Antibiotics as Adjuncts to Periodontal Therapy:Pharmacokinetic Considerations and Dosing Strategies

Led by University of Geneva, Switzerland · Updated on 2026-04-29

45

Participants Needed

1

Research Sites

378 weeks

Total Duration

On this page

Sponsors

U

University of Geneva, Switzerland

Lead Sponsor

U

University of Lausanne

Collaborating Sponsor

AI-Summary

What this Trial Is About

Periodontitits is a bacteria induced inflammatory disease that destroys the supporting tissues of the tooth and leads to tooth loss. Treatment consists mainly of the mechanical cleaning of the tooth surfaces in order to remove the bacterial deposits (plaque and calculus). This procedure can reduce the level of pathogenic bacteria but it can not eradicate them. In severe cases, for the complete resolution of the disease, the elimantion of certain species of bacteria is needed. In order to achieve that, the combination of different regimens of antibiotics adjunctive to the mechanical treatment has been proposed. However, dosage and duration of antimicrobial therapy should be optimal and not excessive as issues may arise related to increased antimicrobial resistance in the population and the individual due to habitual prescription of wide-spectrum antibiotic regimens, horizontal gene transfer and genetic mutation. In the present study, in an effort to optimize the dosage and duration of the antimicrobial regimen, we will determine the pharmacokinetics (PK) and pharmacodynamic (PD) properties of the MET-AMO combination and of AZI in Gingival Crevicular Fluid (GCF), saliva and serum in severe periodontitis patients during and after either a 3-day or a 7-day course of treatment.

CONDITIONS

Official Title

Antibiotics as Adjuncts to Periodontal Therapy:Pharmacokinetic Considerations and Dosing Strategies

Who Can Participate

Age: 18Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent
  • Age between 18 and 80 years old
  • Need for periodontal treatment with adjunctive antibiotic therapy
  • At least 30% of teeth with probing depth greater than 6 mm and bleeding on probing
Not Eligible

You will not qualify if you...

  • Having systemic illnesses such as uncontrolled diabetes, cancer, HIV, bone metabolic diseases, or conditions impairing wound healing
  • Pregnancy or lactation
  • Antibiotic use within the previous 2 months
  • Current use of nonsteroidal anti-inflammatory drugs
  • Known or suspected allergy to 5-nitroimidazole derivatives, amoxicillin, or macrolides
  • Periodontal therapy within the last year
  • Known or suspected non-compliance, drug or alcohol abuse
  • Inability to participate due to language, psychological, or cognitive issues
  • Unwillingness to attend regular dental visits and follow-up
  • Participation in another investigational drug study within 30 days before or during this study

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Geneva, University Clinics of Dental Medicine

Geneva, Canton of Geneva, Switzerland, 1205

Actively Recruiting

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Research Team

C

Catherine Giannopoulou, Dr med dent

CONTACT

A

Alkisti Zekeridou, Dr med dent

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Antibiotics as Adjuncts to Periodontal Therapy:Pharmacokinetic Considerations and Dosing Strategies | DecenTrialz